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The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.
This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.
The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benign group | Patients with benign cervical histology, including normal findings, inflammation and LSIL |
| |
| HSIL group | Patients with cervical histology of HSIL |
| |
| Cancer group | Patients with cervical histology of cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA methylation | Diagnostic Test | DNA methylation for the cervical cytology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of DNA methylation | Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL | 1 years |
| Specificity of DNA methylation | Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value of DNA methylation | Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL | 1 year |
| Negative predictive value of DNA methylation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | +8613911988831 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019175 | DNA Methylation |
| ID | Term |
|---|---|
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
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| high-risk HPV | Diagnostic Test | High-risk HPV testing for the cervical cytology |
|
| TCT | Diagnostic Test | Thin prep liquid-based cytology test for the cervical cytology |
|
Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
| 1 year |
| Correlation coefficient of DNA methylation with other screening methods | Correlation coefficient of DNA methylation with high-risk HPV and TCT results | 1 year |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008660 |
| Metabolism |
| D055614 | Genetic Phenomena |